Rotational Thrombectomy Wire With Blocking Device

ABSTRACT

A thrombectomy apparatus for breaking up thrombus or other obstructive material in a lumen of a vascular graft or vessel. The apparatus includes a wire having a first configuration and a second deployed configuration, the wire having a straighter configuration in the first configuration. The wire is operatively connected to a motor for rotation of the wire to contact and break up the thrombus or other obstructive material. A blocking device at a distal portion of the apparatus is movable between a collapsed configuration and an expanded configuration, and is configured in the expanded configuration to block thrombus dislodged by rotation of the wire.

This application is a continuation in part of U.S. patent applicationSer. No. 12/631,787, filed Dec. 4, 2009, which is a continuation of U.S.patent application Ser. No. 11/267,379, filed Nov. 4, 2005, which is acontinuation of U.S. patent application Ser. No. 09/888,149, filed Jun.22, 2001, which is a continuation in part of Patent Cooperation TreatyApplication No. PCT/US00/41355, filed Oct. 20, 2000, which designatesthe United States, priority from the filing date of which is herebyclaimed under 35 U.S.C. §120, which PCT application claims the benefitof U.S. Provisional Patent Applications No. 60/214,331 filed Jun. 27,2000, and No. 60/161,124 filed Oct. 22, 1999, the benefit of which ishereby claimed under 35 U.S.C. §119. The entire contents of each ofthese applications are incorporated herein by reference.

BACKGROUND

1. Technical Field

This application relates to a rotational thrombectomy wire for clearingthrombus from native vessels.

2. Background of Related Art

There have been various attempts to break up clots and other obstructingmaterial in the graft. One approach is through injection of thrombolyticagents such as urokinase or streptokinase. These agents, however, areexpensive, require lengthier hospital procedures and create risks ofdrug toxicity and bleeding complications as the clots are broken.

Other approaches to breaking up clots involve mechanical thrombectomydevices. For example, U.S. Pat. No. 5,766,191 discloses a cage or basketcomposed of six memory wires that expand to press against the innerlumen to conform to the size and shape of the lumen. This multiple wiredevice is expensive and can be traumatic to the graft, possibly causingdamage, since as the basket rotates, the graft is contacted multipletimes by the spinning wires. Other risks associated with the basketinclude the possibility of catching onto the graft itself and tearingthe graft as well as catching and tearing the suture at the anastomoticsite. Additionally, the basket can become filled with a clot which wouldthen require time consuming withdrawal of the basket, cleaning thebasket and reinserting it into the lumen. This device could be traumaticif used in the vessel, could denude endothelium, create vessel spasmsand has the potential for basket and drive shaft fracture.

U.S. Pat. No. 6,090,118, incorporated herein by reference in itsentirety, discloses a wire rotated to create a standing wave to break-upor macerate thrombus. The single wire is less traumatic than theaforedescribed basket device since it minimizes contact with the graftwall while still effectively mechanically removing thrombotic material.

U.S. Pat. No. 7,645,261, the entire contents of which are incorporatedherein by reference, discloses a thrombectomy device having a doubleballoon structure. This device advantageously reduces the number ofindividual catheters required to perform the thrombectomy procedure andreduces the number of surgical steps, thus simplifying the procedure andreducing operating costs.

U.S. Pat. No. 7,037,316, the entire contents of which is incorporatedherein by reference discloses another example of a rotationalthrombectomy wire for breaking up clots in grafts. The thrombectomy wirehas a sinuous shape at its distal end and is contained within a sheathin a substantially straight non-deployed position. When the sheath isretracted, the distal portion of the wire is exposed to enable the wireto return to its non-linear sinuous configuration. The wire is composedof two stainless steel wires wound side by side with an elastomeric tipat the distalmost end. Actuation of the motor causes rotational movementof the wire, creating a wave pattern, to macerate thrombus. Thus, itprovides the additional advantages of increased reliability andconsistency in creating the wave pattern since the wave pattern createdby the standing wave of the '118 patent will depend more on therotational speed and the stiffness of the wire. Additionally, thesinuous configuration enables creation of a wave pattern at a lowerrotational speed.

Although the sinuous wire of the '316 patent is effective in properclinical use to macerate thrombus in dialysis grafts, it is not bestsuited for use in native vessels. US patent publication no.2006/0106407, the entire contents of which are incorporated herein byreference, discloses a thrombectomy wire better suited for use in nativevessels, and can also be used for deep vein thrombosis and pulmonaryembolisms.

In certain thrombectomy procedures, such as in neurovascular orpulmonary procedures, during wire rotation, broken plaque particleswhich are dislodged can travel through the vascular system. If theseparticles are too large, then they can create risks for the patient asthey travel downstream through the vessels, causing clots which canresult in stroke or in certain instances death of the patient. It wouldbe advantageous to reduce these risks in these procedures.

SUMMARY

The present invention advantageously provides a rotational thrombectomyapparatus for breaking up thrombus or other obstructive material in alumen of a vascular graft or vessel. The apparatus comprises a wirerelatively movable with respect to a flexible sheath and has a firstconfiguration and a second deployed configuration, the wire having astraighter configuration in the first configuration. The wire isoperatively connected to a motor for rotation of the wire to contact andbreak up the thrombus or other obstructive material. A blocking deviceat a distal portion of the apparatus is movable between a collapsedconfiguration and an expanded configuration, the blocking device in theexpanded configuration configured to block thrombus dislodged byrotation of the wire.

In some embodiments, the wire is sinuous in configuration and assumesits sinuous configuration when in the deployed configuration. The wirecan be composed of an inner core and an outer coil. In some embodiments,the wire terminates in a C or J-tip wherein rotation creates at leastone vibrational node.

Preferably, the wire spins independent of the blocking device such thatthe blocking device remains substantially stationary (non-rotational)during rotation of the wire.

The blocking device preferably includes a shaft or tubular portionconnected to a distal end of the wire wherein the wire is rotatableindependent of the shaft or tubular portion.

The apparatus can include one or two inflatable balloons, the balloon(s)spaced proximally of a distal tip of the wire. One balloon can be anangioplasty balloon and one balloon can be configured for engaging andpulling an arterial plug. In some embodiments, the first balloon ispositioned proximal of the second balloon.

The apparatus can includes a housing, wherein the wire extends from thehousing and the housing preferably further includes a battery and amotor for causing rotation of the wire.

In some embodiments, the blocking device includes a plurality of wiresand a porous material covering at least a portion of the wires. Thematerial in some embodiments covers only a distal portion of the wires.In some embodiments, the material covers the entire portion of thewires. The material can be attached to an outer surface and/or innersurface of the wires. In some embodiments, the wires are expandable toexpand a material overlying the wires.

In another aspect, the present invention provides a thrombectomyapparatus for breaking up thrombotic material comprising a rotatablewire having a non-linear configuration, a blocking device positioned ata distal portion of the wire distal of the non-linear configuration toexpand radially with respect to the wire, and a motor for rotating thewire to break up thrombotic material as the wire rotates about its axis.

The apparatus can include a flexible tube with the wire rotatable withrespect to the flexible tube. Preferably, the wire is rotatableindependent of the blocking device.

In another aspect, the present invention provides a method for breakingup the thrombotic material from a lumen of a vascular graft or vesselcomprising;

inserting a sheath;

exposing a rotatable wire of a thrombectomy apparatus from the sheath;

rotating the wire to break up thrombotic material; and

blocking at least some of the thrombotic material with a blocking deviceconnected to a distal portion of the apparatus.

In some embodiments, the step of exposing a rotatable wire from thesheath changes the shape of the wire. In some embodiments, the step ofrotating the wire includes the step of rotating the wire while theblocking device does not rotate.

Preferably, the blocking device is movable between a collapsed andexpanded position.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiment(s) of the present disclosure are described hereinwith reference to the drawings wherein:

FIG. 1 is a perspective view of a first embodiment of a thrombectomyapparatus of the present invention;

FIG. 1A is a perspective view of an alternate housing having a lockingslot for the flexible sheath;

FIG. 2 is a perspective view of a distal portion of an alternativeembodiment of a thrombectomy apparatus of the present invention;

FIGS. 2A and 2B are perspective and side views, respectively of aproximal portion of the apparatus of FIGS. 1 and 2 with a housing halfremoved to illustrate the internal components;

FIG. 3 is a side view illustrating the blocking device of FIG. 2 in acollapsed position within the sheath;

FIG. 4 is an enlarged side view of the blocking device of FIG. 2 in theexpanded (deployed) position exposed from the sheath as the sheath isretracted;

FIG. 5 is an enlarged side view of the thrombectomy wire and theblocking device of FIG. 2 in the deployed position exposed from thesheath as the sheath is further retracted;

FIG. 6 is a perspective view illustrating an embodiment of theattachment of the blocking device of FIG. 2 to the thrombectomy wire;

FIG. 6A is a perspective view illustrating a second embodiment of theattachment of the blocking device of FIG. 2 to the thrombectomy wire;

FIG. 7 is a perspective view of the area of detail of FIG. 1illustrating an embodiment of the attachment of the blocking device ofFIG. 1 to the thrombectomy wire;

FIG. 8 is a perspective view illustrating rotation of the thrombectomywire of FIG. 2;

FIG. 9 is a perspective view of an alternate embodiment of the blockingdevice;

FIG. 10 is side view of the device of FIG. 9 in the collapsed positionwithin a sheath;

FIG. 11 is a perspective view of an alternate embodiment of thethrombectomy apparatus of the present invention having two balloons;

FIG. 12 is a cross-sectional view taken along line 12-12 of FIG. 11;

FIG. 13 is an enlarged view of the distal end of the apparatus of FIG.12, showing the distal balloon in the inflated condition and theblocking device in the expanded position;

FIG. 13A is a side view of another alternate embodiment of thethrombectomy apparatus showing the wire and blocking device of FIG. 2with a balloon, the balloon and the blocking device shown in thedeployed configuration;

FIG. 14 is a perspective view of another alternate embodiment of theblocking device of the present invention;

FIG. 15 is a side view of the blocking device of FIG. 14;

FIGS. 16-18 illustrate one insertion method of the apparatus of FIG. 2into a carotid artery;

FIG. 19 illustrates an alternate embodiment of the thrombectomy deviceof the present invention with the blocking device in the deployedposition; and

FIG. 20 illustrates an alternate embodiment of the thrombectomy deviceof the present invention with the blocking device in the deployedposition.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now in detail to the drawings where like reference numeralsidentify similar or like components throughout the several views, FIG. 1illustrates a first embodiment of the wire of the thrombectomy apparatusof the present invention and FIG. 2 illustrates a second embodiment ofthe wire of the thrombectomy apparatus of the present invention. Each ofthe devices of FIGS. 1 and 2 has a particle blocking device at thedistal end configured to block large dislodged particles during thethrombectomy procedure to block their travel downstream. In both theseembodiments, the blocking device is attached to the wire such that itdoes not rotate when the wire spins. This is described in more detailbelow.

The thrombectomy apparatus of FIG. 1 is designated generally byreference numeral 10. The apparatus includes a housing 12 composed oftwo housing halves 12 a, 12 b, a flexible tube or sheath 40 and arotational thrombectomy wire 60 contained within the flexible sheath 40.A knob 42, extending from distal end 14 of housing 12, is attached tothe flexible sheath 40 to enable both rotation and sliding movement ofthe flexible sheath (tube) 40 with respect to the wire 60 which is fixedaxially. Note that although the flexible sheath 40 is shown as slidableand the wire 60 is fixed axially, alternatively, the wire can be axiallyslidable with the sheath 40 stationary, or both the wire 60 and sheath40 can be slidable. In any case, such relative movement of the wire 60and sheath 40 will enable the wire 60 to be exposed to assume the curvedconfiguration described below to enable removal of obstructions, such asblood clots, from the lumen of the vascular structure. i.e. the vasculargraft or the vessel wall.

It is also contemplated that the wire can be a separatecomponent/assembly insertable into a separate sheath component/assemblyeither prior to insertion into the body or after the sheath is alreadyplaced in the body. In the latter, the sheath can be inserted to thetarget site over a placement guidewire and then the guidewire removedfor insertion of the thrombectomy wire into the already placed sheath.The wire would include a housing containing a motor or attachable to ahousing containing a motor either prior to or after insertion throughthe sheath.

Contained within housing 12 is a motor powered by a battery containedwithin a compartment in the housing accessible by removing battery door33. An actuation button is electrically connected to one contactterminal of the battery and the motor is electrically connected toanother contact terminal of the battery. The actuation button can beconnected to the motor via a wire strip such that depression of thebutton, which is accessible from a portion of housing 12, turns on themotor to activate the apparatus.

Wire 10 (or wire 100 discussed below) is operatively connected to themotor. Operative connection encompasses direct connection or connectionvia interposing components to enable rotation when the motor isactuated.

In one embodiment, the wire 60 is operatively connected to the motor viaa support tube which is preferably composed of metal. A speed reducinggear can be provided to decrease the rotational speed. When the motor isenergized, the support tube is rotated about its longitudinal axis, viarotation of a chuck driven by gears, thereby rotating the wire 60 aboutits longitudinal axis. This rotation of wire 60 creates at least onevortex that macerates and liquefies the thrombus into small particleswithin the vascular lumen. Further details of the internal componentswhich can be utilized to connect and rotate the wire are illustrated anddescribed in U.S. Pat. No. 7,507,246, the entire contents of which areincorporated herein by reference. Such arrangement can also be used toconnect and spin the thrombectomy wire of the embodiment of FIG. 2 aswell as the other embodiments described herein.

As noted above, flexible tube (sheath) 40 is slidable with respect tothe housing 12 and wire 60. Flexible tube 40 is also rotatable. Knob 42can have a gripping region 46. Sliding movement of knob 42 accordinglyslides sheath 40 axially and rotation of knob 42 accordingly rotatessheath 40 about its longitudinal axis. Proximal sliding movement of knob42 exposes rotational wire 60, enabling it to assume its curvedconfiguration; rotation of knob 42 orients the rotational wire 60 due tothe J-shaped distal end. The gripping region 46 and/or extension 48 ofknob 42 can contain external threads (not shown) for threaded engagementwith the distal end of housing 12 to lock the sheath 40 in the advancedand retracted positions to maintain exposure or covering of the wire 60.

As an alternative, a locking slot 80 can be provided as in FIG. 1A. Slot80 is formed in housing 12′. Post 81 extends radially from the sheath40′ and is movable radially into radial slot portion 82 of elongatedaxial slot 80 to a locking position or movable radially into radial slotportion 84 of elongated slot 80 to another locking position torespectively retain the sheath 40′ in its advanced position to cover thewire 60 or retracted position to expose the wire 60. Such lockingpost/slot arrangement can also be used to uncover and cover wire 160 inthe alternate apparatus of FIG. 2 as well as the other wires disclosedherein. Thus, to advance the sheath 40′ to cover the wire 60, post 81would be moved radially in the direction of arrow A1, slid axially inslot 80 in the direction of arrow A2, and then moved radially into slotportion 82 in the direction of arrow A3. To retract and lock the sheath40′ to expose wire 60, the post 81 would be moved in the reversedirection into radial slot portion 84.

The flexible sheath 40 can optionally contain one or more braided wiresembedded in the wall to increase the stiffness. Such braided wires couldpreferably extend the length of the sheath 40.

It is also contemplated as noted above that the thrombectomy wiresdisclosed herein can be provided without a sheath and inserted into oran already placed sheath in the body or inserted into a sheath and thentogether placed in the body.

Extension arm 52 of the Touhy borst positioned within housing 12 has alumen communicating with the lumen of flexible sheath 40. Fluids such asimaging dye can be injected through arm 52, flowing through sheath 40 inthe space between wire 60 and the inner wall of the sheath 40, andexiting a distal opening to flow into the graft or vessel. This imagingdye can be used to provide an indication that fluid flow has resumed inthe graft or vessel. The Touhy can contain a conventional siliconegasket which is compressed when tightened to provide a seal to preventback flow of fluid around the support tube. A radiopaque marker can beprovided in the apparatus for imaging to visually locate the position ofthe apparatus. Such extension arm connection and structure can also beutilized with the FIG. 2 embodiment such that fluid can exit distalopening 141 (see FIG. 4).

An alternate wire connection is illustrated in FIGS. 2A and 2B with oneof the housing halves removed to illustrate the internal components.Coupler 406 having a washer 408 extends from motor 410 (powered bybattery 413) which is seated within housing half 411 a. Slide 412 haspost 414 extending therefrom for access through the housing for the userto advance and retract the sheath 418. Post 414 locks the sheath in anadvanced position (FIG. 2A) and a retracted position as it engagesrespective distal or proximal slot 421, 423. Extension arm 420 enablesfluid injection through sheath 418.

Referring back to FIG. 1, the wire 60 terminates in a J-tipconfiguration at region 61. Due to this angle, when the wire is rotatedby the motor at sufficient speed, at least one vibrational node isformed. Details of this J-tip wire are described in U.S. Pat. No.6,090,118, the entire contents of which are incorporated herein byreference. This patent also describes creation of a standing wave.

A clot blocking device in the form of a basket 70 is connected to thewire 60. The device can also be configured to capture the clots. Thebasket 70 has a proximal portion 72 and a distal portion 74. Proximalportion converges into tubular portion 71 and distal portion 74converges into tubular portion 73. Distal tubular portion 73 includes asoft atraumatic tip 76 attached thereto which can be composed of rubber,Pebax or other elastomeric materials to provide an atraumatic distal endto prevent damage to the vessel wall during manipulation. The proximalportion 72 has a curved tube 78 (either integral or attached) which isconfigured for connection to a distal portion of wire 60. Variousmethods of attachment can be utilized. The attachment methods enable thewire 60 to spin while the blocking device does not spin and remainssubstantially stationary. One example of an attachment structure isshown, in FIG. 7 wherein wire 60 can have an O-ring positioned thereoverwhich is seated within a recess (as in the embodiment 6 of FIG. 6described below) of curved connector tube 78 of blocking device 70. Thisattachment allows the wire 60 to spin inside the lumen of the tube 78.Other attachments for independent rotation are also contemplated. Thecurved tube 78 is configured so that a central longitudinal axis of theblocking device 70 is substantially aligned with a central longitudinalaxis of the thrombectomy catheter 10. That is, the tube bends in aU-shape so a distal end 79 of the tube is aligned with sheath 40 andwith the proximal tubular portion 71 of blocking device 70.

The blocking device 70 is movable between an initial collapsed positionwithin the sheath 40 for delivery and an expanded deployed configurationwhen exposed from the sheath. Such collapsed and expanded positions areshown in FIGS. 3 and 4 in conjunction with the wire 160 of FIG. 2 whichis applicable to the blocking device 70 of FIG. 1 as FIGS. 1 and 2differ in the configuration of the wire, but have the same blockingdevice. More details of the blocking device are discussed below.

Turning to the alternate embodiment of the wire of FIG. 2, therotational thrombectomy wire 160 in its expanded (deployed)configuration assumes a substantially sinuous configuration. Thissinuous configuration resembles a sine curve.

Wire 160 has a substantially linear portion extending through most ofits length, from a proximal region, through an intermediate region todistal region 166. At the distal region 166, wire 160 has a sinuousshape in that as shown it has a first arcuate region 163 facing a firstdirection (upwardly as viewed in the orientation of FIG. 5) and a secondarcuate region 165, spaced longitudinally from the first arcuate region163, facing a second opposite direction (downwardly as viewed in theorientation of FIG. 5). These arcuate regions 163, 165 form “peaks” tocontact vascular structure as the wire 160 rotates. The distal tip ofwire 160 can continue upwardly as a continuation of the “sine curve”configuration. An atraumatic tip 176, preferably composed of rubber,Pebax, or other elastomeric materials, although other materials are alsocontemplated, is inserted, molded or otherwise attached to thedistalmost tip (e.g. distal tubular portion 173 formed at the distalconverging region) of the blocking device 170 to provide the apparatus100 with an atraumatic distal tip to prevent damage to the graft orvessel wall during manipulation of the wire 160 and blocking device 170.

When the sheath (tube) 140 is in the advanced position as in FIG. 3, thecurved regions of the wire 160 are compressed so the wire 160 (includingthe distal region 166) is contained in the flexible sheath 140 in asubstantially straight or linear non-deployed configuration. Thecapturing device 170 is also in a substantially straight position withinthe sheath 140 in the initial position. This covering of the wire 160and device 170 by sheath 140 facilitates insertion through theintroducer sheath and manipulation within the vascular structure. Whenthe sheath 140 is retracted by proximal axial movement of the knob (inthe same manner as knob 42 of FIG. 1) or by the post 81 in the FIG. 1Aor 2A embodiment, the blocking device 170 and the distal region 166 ofthe wire 160 are exposed to enable the blocking device 170 to return toits expanded configuration and enable wire 160 to return to itsnon-linear sinuous configuration shown in FIGS. 2 and 5. The wire 160 ispreferably composed of stainless steel which is pre-bent to the curvedconfiguration of FIG. 5 and returns to this position when released fromthe flexible sheath 140.

In one embodiment, the wire 160 is composed of an inner core and outerlayer or coil. The inner core can be formed by twisting a series ofwires together in a tight configuration. The outer coil can be formed bywinding a wire, preferably of larger diameter, to form an openingtherethrough. This tightly wound outer/inner core structure enablesrotation of the distal end of the wire 160 corresponding to rotation atits proximal end as torque is transmitted to the distal end.

Various dimensions of the wire and flexible tube are contemplated. Byway of example only, in one embodiment, where the flexible tube 140 hasan outer diameter of about 0.062 inches, the curved regions of the wire160 would extend from the longitudinal axis a distance of about 0.188inches and the radius of curvature at region 165 would be about 0.376inches in a wire having an overall diameter (combined outer coil andinner core) of about 0.035 inches. As can be appreciated, thesedimensions are provided by way of example as other dimensions are alsocontemplated.

In an alternate embodiment of the sinuous thrombectomy wire, the wireincludes a core, a bifilar wire (coil), and shrink wrap. The core can beformed by multiple twisted wires. The bifilar wire can be formed by twowires wound together, and wound side by side so the cross-sectional areaor diameter of the wire fills the space between adjacent turns of theother wire. The distal region of the bifilar wire is formed into asinuous or s-shape to contact the vessel wall as the wire rotates.Although in the preferred embodiment the outer wire is a multifilar wirein the form of a bifilar wire (two wires), a different number of wirescould be wound to form the outer wire component of the thrombectomywire, including a single wound wire.

In this embodiment, the core is positioned within the bifilar wire andpreferably has an outer diameter substantially equal to the innerdiameter of the coil. The core has a sinuous shaped portion within thesinuous shaped portion of the outer wire, corresponding to the sinuousshape. In one embodiment, the core extends the entire length of thebifilar wire. The core can alternatively have a length of about 4-5inches so it extends through the distal linear portion and sinuousportion of the wire.

The core in this embodiment can be composed of a flexible material whichwill limit the compressibility of the wire during use. The core can becomposed of Nylon, and preferably a drawn Nylon monofilament. Otherpossible materials include, for example, Teflon, polypropylene, PET, andfluorocarbon as well as shape memory material such as Nitinol. The Nylonprovides a non-compressible material to limit the compressibility of thewire during use. This enables the coil (bifilar wire) to compress onlyto that diameter. By limiting compressibility it strengthens the wire asit reduces its degree of elongation if it is under torque. It alsoprevents bending or knotting of the wire which could otherwise occur innative vessels. It increases the torsional strength of the wire and alsostrengthens the wire to accommodate spasms occurring in the vessel. Thecore can be attached by adhesive at the tip, welded, crimped, solderedor can alternatively be free floating.

A shrink wrap material can cover a distal portion of the bifilar wire toblock the interstices of the coil and provide a less abrasive surface.The shrink wrap can be made of PET, Teflon, Pebax, polyurethane or otherpolymeric materials. The material can extend over the exposed portion ofthe wire (preferably for about 3 inches to about 4 inches) and helps toprevent the native vessel from being caught in the coil and reducesvessel spasms. Alternatively, instead of shrink wrap, a coating can beapplied to the coil formed by the bifilar wire to cover the interstices.(Examples of coatings which can be utilized include hydrophilic coatingsand PTFE.)

In the embodiment of a core of shape memory material, the memorizedconfiguration is sinuous or s-shape substantially corresponding to thes-shape of the bifilar wire. In the softer state within the sheath, thecore is in a substantially linear configuration. This state is used fordelivering the wire to the surgical site. When the wire is exposed towarmer body temperature, or when released from the constraints of thesheath, the core transforms to its austenitic state, assuming thes-shaped memorized configuration.

The Nitinol core, like the Nylon core, is not compressible so it willalso limit the compressibility of the bifilar wire. The Nitinol corealso will increase the stiffness of the wire thereby reducing the chanceof knotting and kinking and increase the strength of the wire toaccommodate any spasms in the vessel. Its shape memory helps hold theamplitude of the bifilar wire during use to maintain its force againstthe clot for maceration upon rotation. It preferably extends about 4-5inches so it extends through the distal linear portion and sinuousportion of the wire. It can alternatively extend a shorter or longerlength within the wire, or even the entire length.

In another embodiment, a stainless steel braid, cable, or strand ofwires twisted together provides the inner core member to limitcompressibility of the coil (bifilar wire) and provide increasedstiffness, strength and other advantages of the core enumerated above.

Further details of the wire are disclosed in pending Patent PublicationNo. 2006/0106407 published May 18, 2006, the entire contents of whichare incorporated herein by reference.

Turning now to the clot blocking device, the blocking device will now bedescribed in conjunction with FIGS. 2-5 and 8, which show the sinuouswire configuration. It should be understood that the same clot blockingdevices can be used with the J-wire embodiment of FIG. 1, however, forbrevity, only its use with the sinuous wire of FIG. 2 will be describedin detail.

The blocking device 170 is positioned distally of the thrombectomy wire160 and is therefore exposed before the wire during use. The device 170includes a plurality of wires 172. The wires 172 are movable from acompressed configuration, positioned inside the sheath 140 (FIG. 3), toan expanded configuration when exposed from the sheath as shown in FIG.4. The wires 172 extend longitudinally and expand radially when releasedfrom the sheath 140 and can be made of a material with sufficientspringiness or alternatively made of shape memory material with amemorized expanded configuration. A membrane 180 with pores ofsufficient size to allow blood flow therethrough but small enough toblock thrombus or other particles which could pose a risk to the patientcovers the wires 170. The membrane 180 can cover the entire “cage” or“basket” formed by the wires 172 or optionally can be disposed only overa region of the wires 172, such as the distal half as shown in FIG. 4.Also, the membrane 180 can be attached to an outer surface and/or aninner surface of the wires 172. As shown, the wires 172 expand radiallywith respect to a longitudinal axis of the catheter. Although six wiresare shown, a different number of wires could be provided to support themembrane 180.

The blocking device 170 (as well as the alternate blocking devices 200,300 described below) can be utilized with any of the rotationalthrombectomy wires described herein as well as with other thrombectomydevices to block particles dislodged during the thrombectomy procedure.

FIG. 6 illustrates one embodiment of attachment of the capturing device170 to wire 160 to enable independent rotation of the thrombectomy wire160. The distal end of wire 160 has an O-ring 192 configured to beseated within a groove 177 in proximal tubular portion or shaft 179 ofblocking device 170. Note the wire 160 in this embodiment steps down toform reduced diameter region 169 to accommodate the O-ring 192 tomaintain the diameters of the wire 160 and tubular portion 179substantially flush. Such groove engagement enables wire 160 to spinwithout spinning the blocking device 170.

FIG. 6A illustrates an alternate attachment configuration. The distalend 167′ of wire 160′ terminates in a ball tip 190 which is seatedwithin groove 177′ of proximal tubular portion or shaft 179′ of blockingdevice 170 to enable the wire 160 to spin within tubular portion 179′without spinning the blocking device 170. Other connections to achieverotation are also contemplated. Note wire 160 steps down to form areduced diameter region 169′.

In the alternate embodiment of FIG. 9, blocking device 200 includes twolooped wires 212, 214. In the collapsed configuration of FIG. 10, thewires 212, 214 are in an elongated position substantially parallel withthe longitudinal axis of the catheter. The wires 212, 214 are maintainedin this configuration by the sheath 240. The membrane 280 is attached tothe wires either to an outer surface and/or an inner surface and can beattached to cover only a portion, e.g. the distal portion, or the entireportion of the wires 212, 214. Although two wires are shown, more wirescould be provided. Also, alternatively a single wire could be provided.

When the blocking device 200 is exposed from the sheath 240, the wires212, 214 automatically move to their expanded position to form loops.The wires can be made of springy material or shape memory material. Ends212 a, 214 a extend distally from proximal tubular portion 240 and ends212 b, 214 b extend proximally from distal tubular portion 241. That is,a first looped wire region is formed by each wire 212, 214 on one sideof a longitudinal axis of the apparatus and a second looped wire regionis formed by each wire 212, 214 on the other side of the longitudinalaxis of the apparatus, preferably about 180 degrees apart. This doublelooped configuration causes the membrane 280 to be stretched on opposingsides of the device and preferably block about a 360 degree area. Thus,the stretching of membrane 280 on both sides of the device to theillustrated expanded configuration of FIG. 9 blocks the flow of selectmaterial. The membrane 280 preferably has pores to provide openings forblood flow, with the membrane 280 blocking flow of materials exceedingthe pore size.

The expanded loops of the wires 212, 214 thus lie in a plane at an angleto both the longitudinal axis and transverse axis of the apparatus(catheter). In other words, the plane of the loop opening would be at anangle (preferably at a slight angle) to the longitudinal and transverseaxis of the sheath 240. The wires 212, 214 would thus extend such thatthe loop opening is slightly offset from the direction of thelongitudinal axis of sheath 240 but still open generally in thedirection of blood flow. That is, a central longitudinal axis extendingthrough the loop opening would be at an angle with respect to thelongitudinal axis of the sheath 240. Alternate wire loops and membranesare disclosed in commonly assigned U.S. Pat. Nos. 7,604,649 and7,331,976, the entire contents each of which are incorporated herein byreference. For example, the wire can be configured so the two loopedsections are axially offset as shown in FIG. 28 of U.S. Pat. No.7,604,649.

Consequently, in some embodiments, the plane of the loop opening isperpendicular to the longitudinal axis of the catheter (parallel to thetransverse axis) and perpendicular to the direction of blood flow. Inother embodiments, rather than perpendicular, the plane of the loopopening is at an angle less than 90 degrees, but preferably greater thanabout 45 degrees to the longitudinal axis.

The expansion movement of the wires causes the overlying membrane to bedeployed, moving to an expanded position. The membranes 180 (and 80, 280and 380 discussed herein) can be a polymeric membrane, such aspolyurethane or PET, which is expanded by the wires. A mouth or openinge.g. opening 171 of FIG. 8 can be provided at the proximal end of themembrane. The polymeric material would have small holes or windowsdimensioned for allowing blood flow while blocking embolic material.Thus, embolic material exceeding a certain size carried by the blood isblocked with smaller particles flowing through the holes or pores in themembrane.

Alternatively, the blocking device can be a tightly wound metal braidedmaterial such as shape memory metal, e.g. Nitinol.

To withdraw the blocking device, the sheath and/or wires are moved toretract the loop and membrane to the initial low profile insertionposition within the sheath 240.

Another alternate embodiment of the blocking device is designated byreference numeral 300 in FIGS. 14 and 15. The device has a plurality ofwires 310 extending distally from proximal tubular portion 315 atconverging end 313 and terminating in free ends 316. The tips 316 a ofthe wires 310 can curve slightly radially inwardly as shown. Althoughsix wires are shown, a different number of wires can be provided. Themembrane 370 is positioned over the wires 310 but can alternatively beattached to an inner surface of wires 310. Although shown as positionedover a distal portion of wires 310, the membrane 370 can be positionedover other portions or the entire portion as discussed above withrespect to the other membranes. The membrane 370 can also be attached todistal tubular portion 319 of the device 370, which is proximal of thesoft atraumatic tip 321. As with the other membranes disclosed herein, aplurality of pores are preferably provided. The blocking device 300 (aswell as blocking device 200 described above) can be connected to thethrombectomy wire 160 or 60 in the ways described above, or inalternative methods, which enable spinning of the thrombectomy wirewithout corresponding spinning of the blocking device 370.

In use of the thrombectomy apparatus (catheters) of the presentinvention, which by way of example is shown and described with respectto the embodiment of FIG. 2, it being understood the other thrombectomydevice described herein can be inserted and used in a similar fashion,the thrombectomy apparatus 100 is inserted into the vessel through anaccess sheath (FIG. 16) in the femoral artery F and located via imaging.The device is advanced to the desired site and once in the selectvessel, the flexible sheath 140 is retracted to first expose theblocking device, e.g. device 170, to allow expansion of the wires andmembrane to the blocking position, followed by exposure of thethrombectomy wire, e.g. wire 160. Then, actuation button is depressed toactuate the motor, thereby causing wire 160 to rotate about itslongitudinal axis, causing the arcuate regions 163,165 (FIG. 18) todirectly contact and break up the thrombotic material inside the lumenof the graft or vessel. Note that the femoral location of the accesssheath for introducing the thrombectomy apparatus 100 can be appreciatedby the illustration in FIG. 16. Although the wires differ betweenapparatus 10 and apparatus 100, the introducer sheath location could bethe same. The introducer sheaths can optionally have side ports foraspirating the small macerated particles. As shown in FIGS. 17 and 18,the device is advanced for example to the carotid artery.

FIGS. 11-13 illustrate an alternative embodiment of the thrombectomyapparatus of the present invention, designated generally by referencenumeral 500. Thrombectomy apparatus 500 is similar to apparatus 10 ofFIG. 1 except for the provision of two inflatable balloons and twolumens in the sheath (catheter), each communicating with one of theballoons to allow passage of inflation fluid. More specifically,apparatus 500 includes a flexible sheath (tube) 540 and a rotationalwire 560 contained within sheath 540 identical in configuration andfunction to wire 60 of FIG. 1. A knob is rotatable to orient the J-tipand slide sheath 540 to uncover the rotational wire 560 in the samemanner as knob 42 of FIG. 1. Note that FIG. 11 shows both balloonsinflated for illustrative purposes since in the preferred use of theapparatus as discussed in detail below, only one balloon would beinflated at a time.

The flexible sheath 540 of apparatus 500 has a lumen 516, preferablycircular in cross-section, for receiving the rotational wire 560, andfirst and second lumens 513, 514, each communicating with a balloon, forinflating the respectively balloon. More specifically, first lumen 513communicates with angioplasty balloon 520, which is preferably somewhatelliptical shape, and second lumen 514 communicates with balloon 524,which is preferably substantially spherical in shape. Inlet portscommunicate with lumens 513, 514, respectively, to inflate therespective balloons 520, 524.

In this embodiment which provides a double balloon thrombectomyapparatus, the apparatus reduces the procedural steps for thrombusremoval. In the prior art, two independent balloon catheters plus amechanical thrombectomy device are required to perform a thrombectomyprocedure; with the apparatus 500, only one device is required. Thus,the numerous catheter insertions and removals can be avoided.

A clot blocking device such as any of those used with the previousembodiments is positioned at the distal end of the apparatus. Forillustrative purposes, the blocking device 570 shown is identical todevice 170 and the corresponding parts are labeled with designations“500”. Therefore, blocking device 570 has wires 572 and membrane 580.Atraumatic tip 576 is attached to the distal end.

In the embodiment of FIG. 13A, the thrombectomy apparatus of FIG. 2 isprovided with a balloon 624 identical to balloon 524 of FIG. 11. It canalso, additionally or alternatively, include a balloon identical toballoon 520 of FIG. 11. Blocking device 670 is identical to blockingdevice 170 and includes wires 672 and membrane 680. Sinuous wire 660extends from sheath 640. Atraumatic tip 676 is attached to the distalend.

In use of the double balloon thrombectomy device of FIG. 11, the venousaccess sheath is inserted, the thrombectomy device which contains anangioplasty balloon 520 is inserted through the sheath so tip 576extends past the plaque. Angioplasty balloon 520 is inflated via lumen513 to remove and compress the plaque P to open the lumen. Note theblocking device 570, positioned distal of balloon 520, is in theexpanded configuration to block the flow of large plaque particles. Theangioplasty balloon 520 is then deflated and the apparatus 500 is movedproximally so the rotational thrombectomy wire 560 is in the region ofthe blood clot. The apparatus is then activated to spin the wire 560 tobreak up the thrombus and other obstructive material. The wire can havea J-tip as in FIG. 1 or a sinuous configuration as in FIG. 2. Suctioncan then optionally be applied either with the apparatus in place, withthe particles being removed through the gap between the flexible sheath540 and the introducer sheath, or the apparatus can be removed andsuction applied through the introducer sheath. Particles captured by theblocking device 570 can also be removed by suction. The blocking device570 in the expanded configuration of FIG. 13 blocks the flow of largeclots.

After breaking up the blood clot, if used in a dialysis graft clearingprocedure, the apparatus is removed from venous access sheath andinserted through an arterial access sheath. The apparatus 500 isinserted so the tip extends slightly beyond the arterial anastomoticsite, past the arterial plug (clot), and the spherical distal balloon524 is inflated. The apparatus is then pulled proximally so that balloon524 pulls the arterial plug into the graft G. The thrombectomy apparatus500 can then be actuated to rotate wire 560 to break up the clot andother obstructive material, and optionally the broken particles can beremoved by suction as described above. Particles captured by blockingdevice 570 can also be removed by suction. The thrombectomy apparatus500 is then removed through the arterial access sheath, completing thethrombectomy procedure.

It is also contemplated that as an alternative to the double balloonthrombectomy devices described above, a single balloon thrombectomydevice can be provided. This device could contain either angioplastyballoon 520 or balloon 524. If only balloon 520 is provided, althoughthe procedure would still require a separate balloon catheter to removethe arterial plug, it would still advantageously eliminate the step andexpense of a separate angioplasty catheter. Alternatively, if the singleballoon device contained only balloon 524, although the procedure wouldrequire a separate angioplasty balloon catheter, it would stilladvantageously eliminate the step and expense of a separate ballooncatheter for pulling the arterial plug into the graft.

It should also be appreciated that the double balloon concept tofacilitate and expedite the surgical thrombectomy procedure can beutilized with other thrombectomy devices. For example, mechanicalthrombectomy devices utilizing rotating wire baskets, fluid jet(hydrodynamic) devices applying high pressure fluid, devices utilizingbrushes having bristles to scrape the clot and devices with rotatingimpellers can be modified to incorporate one or more balloons, i.e. anangioplasty and/or distal balloon to perform an angioplasty procedureand/or pull an arterial plug into the graft.

The blocking devices disclosed herein can be utilized with any of thewire embodiments disclosed herein as well as with other thrombectomydevices to block clots from traveling downstream.

FIG. 19 illustrates an alternate embodiment of a thrombectomy apparatus700 having a blocking device 710. The thrombectomy device includes arotatable basket 720 comprising a plurality of wires 722. The wires 722expand to the expanded position shown when exposed from sheath 704.Rotation of basket 720 breaks up thrombus, and blocking device 710,composed of expandable wires 702 and membrane 704, similar to blockingdevice 70, blocks large particles from flowing downstream. The otherblocking devices disclosed herein can also be used with the apparatus700.

In the embodiment of FIG. 20, the wires 722′ of basket 720′ can includea shrink wrap material 724 thereover or a coating as shown to provide aless abrasive surface. The shrink wrap can include PET, Teflon, Pebax,polyurethane or other polymeric materials. This material helps toprevent the native vessel from being caught in the coil and reducevessel spasms. Alternatively, instead of shrink wrap, a coating can beapplied to the wires 722′. Coatings which can be utilized include forexample hydrophilic coatings and PTFE. Blocking device 710′ is identicalto blocking device 710. Other blocking devices could also be utilized.

The various thrombectomy apparatus described herein can be utilized in avariety of applications, including but not limited to grafts, AVfistulas, deep vein thrombosis (e.g. in iliac or femoral vein),pulmonary embolism (e.g. in pulmonary artery) and neuro applications(e.g. in carotid or cerebral arteries).

While the above description contains many specifics, those specificsshould not be construed as limitations on the scope of the disclosure,but merely as exemplifications of preferred embodiments thereof. Thoseskilled in the art will envision many other possible variations that arewithin the scope and spirit of the disclosure as defined by the claimsappended hereto.

1. A thrombectomy apparatus for breaking up thrombus or otherobstructive material in a lumen of a vascular graft or vessel, theapparatus comprising a wire having a first configuration and a seconddeployed configuration when exposed from a sheath, the wire having astraighter configuration in the first configuration, the wire beingoperatively connected to a motor for rotation of the wire to contact andbreak up the thrombus or other obstructive material, and a blockingdevice at a distal portion of the apparatus, the blocking device movablebetween a collapsed configuration and an expanded configuration, theblocking device in the expanded configuration configured to blockthrombus dislodged by rotation of the wire.
 2. The thrombectomyapparatus of claim 1, wherein the wire is sinuous in configuration andassumes its sinuous configuration when in the deployed configuration. 3.The thrombectomy apparatus of claim 1, wherein the wire is composed ofan inner core and an outer coil.
 4. The thrombectomy apparatus of claim1, wherein the wire spins independent of the blocking device such thatthe blocking device remains substantially stationary as the wirerotates.
 5. The thrombectomy apparatus of claim 1, wherein the blockingdevice includes a tubular portion connected to a distal end of the wire,the wire rotatable independent of the tubular portion.
 6. Thethrombectomy apparatus of claim 3, wherein the inner core is composed ofa plurality of wires twisted together.
 7. The thrombectomy apparatus ofclaim 1, wherein the wire terminates in a J-tip.
 8. The thrombectomyapparatus of claim 1, further comprising a flexible sheath.
 9. Thethrombectomy apparatus of claim 5, further comprising an inflatableballoon, the balloon spaced proximally of a distal tip of the wire. 10.The thrombectomy apparatus of claim 1, further comprising a housing, thewire extending from the housing, the housing containing a battery andthe motor for rotating the wire.
 11. The thrombectomy apparatus of claim8, further comprising first and second balloons, and the flexible sheathhas first and second lumens, the first lumen communicating with thefirst balloon and the second lumen communicating with the secondballoon.
 12. The thrombectomy apparatus of claim 11, wherein the firstballoon is an angioplasty balloon and the second balloon is configuredfor engaging and pulling an arterial plug, wherein the first balloon isproximal of the second balloon.
 13. The thrombectomy apparatus of claim1, wherein the blocking device includes a plurality of wires and aporous material covering at least a portion of the wires.
 14. Thethrombectomy apparatus of claim 13, wherein the material covers a distalportion of the wires.
 15. The thrombectomy apparatus of claim 1, whereinthe blocking device includes an expandable material and a plurality ofwires expandable to expand the material.
 16. The thrombectomy apparatusof claim 1, wherein in the second configuration the wire has a firstarcuate region extending in a first direction and a second arcuateregion spaced longitudinally from the first arcuate region and extendingin a second direction, the first and second arcuate regions configuredto break up thrombotic material as the wire spins.
 17. A thrombectomyapparatus for breaking up thrombus comprising a rotatable wire, the wirehaving a non-linear configuration, a blocking device positioned at adistal portion of the wire distally of the non-linear portion of thewire, the blocking device expanding radially with respect to the wire,and a motor for rotating the wire to break up thrombotic material as thewire rotates about its axis.
 18. The apparatus of claim 17, wherein thewire is rotatable independent of the blocking device.
 19. The apparatusof claim 18, wherein the wire includes a multifilar outer wiresurrounding at least a portion of an inner core, the multifilar outerwire including at least first and second metal wires wound side by sideand having a sinuous shaped portion at a distal region and a polymericmaterial surrounding at least a distal portion of the multifilar wire.20. A method for breaking up thrombotic material from a lumen of avascular graft or vessel comprising; inserting a sheath; exposing arotatable wire of a thrombectomy apparatus from the sheath; rotating thewire to break up thrombotic material; and blocking at least some of thethrombotic material with a blocking device positioned at a distalportion of the apparatus.
 21. The method of claim 20, wherein the stepof rotating the wire includes the step of rotating the wire while theblocking device does not rotate.
 22. The method of claim 21, wherein theblocking device is movable between a collapsed position for insertionand an expanded position.